Methods and Apparatus for Treatment of Aneurysms Adjacent Branch Arteries

ABSTRACT

A polymer coating/ring is employed to aid in the sealing and connection of modular elements used in body flow lumens for the exclusion and bypass of diseased regions of the flow lumen, such as where aneurysm occurs adjacent to branching blood vessels.

FIELD OF THE INVENTION

The field of the invention is the treatment of vascular abnormalities.More particularly, the field of the invention is the treatment ofvascular abnormalities by placing an excluding device in a blood vesselto exclude or bypass an abnormality, including placing such an excludingdevice in an area near one or more branch vessels so as to bypass theabnormality, but not occlude the branch vessel.

BACKGROUND OF THE INVENTION

“Aortic aneurysm” is the term used to describe a condition where asegment of the aorta is dilated to a diameter greater than its originaldiameter. Aneurysms can occur in virtually any region of the vasculatureincluding the aorta in the abdominal and thoracic regions. Aorticaneurysms are caused by hardening of the arteries (atherosclerosis),high blood pressure (hypertension), genetic disposition such as Marfan'sSyndrome, trauma, or less common disorders. Atherosclerosis is the mostcommon cause.

Where dilation meets or exceeds 50% of the original aortic diameter,i.e., where the diameter of the aorta is 150% of the original orexpected diameter, intervention generally is deemed necessary. Withoutintervention, the aneurysm may continue to expand, leading to thepossibility of tearing or rupture of the aorta, and death. Interventionincludes techniques such as replacement of the aorta with a syntheticlumen which is sewn to the two ends of the still viable aorta after theaneurysmal portion has been opened or surgically removed, or, lessinvasively, by the endovascular placement of an exclusion device such asa stent graft across the aneurysmal site. The stent graft is a tubularmember designed to provide a conduit enabling blood flow through theaorta without allowing the systemic pressure of the blood to furtherstretch the aneurysm. To enable these conditions, the stent graft mustextend across the weakened blood vessel wall so that the opposed ends ofthe stent graft engage and seal against healthy blood vessel tissue toeither side of the aneurysm.

A stent graft includes a stent framework (stent portion), which providesphysical support of the stent graft in a tubular configuration oncedeployed at a vascular location, and a graft portion, comprising anexcluding material, which is sewn or otherwise attached to the stentportion and which provides a relatively fluid-tight conduit for bloodflow through the stent graft and past the aneurysm site. Insertion of astent graft can be performed without a chest incision using specializedcatheters that are introduced through arteries usually at a location ina leg adjacent the groin.

The aorta has numerous arterial branches. For example, the arch of thethoracic aorta has three major branches, all of which arise from theconvex upper surface of the arch and ascend through the superiorthoracic aperture to the root of the neck. The proximity of an aneurysmto a branch artery may limit the use of an excluding device such as atubular stent graft, as the main body or ends of the tubular stent graftmay occlude or block the branch arteries due to the need to position thestent graft to seal against a healthy, i.e., undiseased or dilatedportion of the artery wall. There may be an inadequate length of healthytissue for the stent graft to seal against in the area between theaneurysmal region of the artery and the location of the branch arteries,or, even if the stent graft initially is located without blocking abranch artery, there still is a risk of migration of the exclusiondevice to a position where it may partially or fully block a branchartery, since aneurysms of the descending aorta commonly occur above andadjacent to the celiac trunk, superior mesenteric and renal arteries.

Therefore, there is a desire in the art to achieve a greater success ofaneurysm repair and healing, and in particular, mechanisms and methodsto enable stent grafting or the placement of other exclusion devicesadjacent to branch vessels in aneurysmal locations.

SUMMARY OF THE INVENTION

Embodiments according to the present invention address aneurysm repairand in situ positional stability of a device used for aneurysm repair.Specifically, embodiments according to the present invention providemethods and apparatus for use in the treatment of aneurysms located nearbranch vessels, using modular, sectional-type stent grafts that excludethe aneurysmal region without blocking or otherwise impeding the flow ofblood to branch arteries. Additionally, these modular stent graftsprovide a tight seal between sections. Although the specificationprovides specific configurations for use in abdominal and thoraciclocations, stent grafts according to the invention are readilyapplicable to uses in other aneurysmal locations where branch vessels orother flow lumen discontinuities are present. Stent graft featuresaccording to the invention can also be used in all modular components ofa stent graft that do not necessarily relate to branch vessels,including junctions between main modular elements and other stent graftextensions such as cuffs.

Thus, in one embodiment according to the invention there is provided amodular exclusion device useful for implantation in an aneurysmal sitein a blood vessel having a branch vessel near the aneurysmal sitecomprising: a main body with at least one aperture; at least one insertwith an insertion end, where a polymeric compound is disposed within theaperture of the main body, on the insertion end of the insert, or bothwithin the aperture of the main body and on the insertion end of theinsert, and where the polymeric compound comes into contact with boththe aperture of the main body and the insertion end of the insert whenthe insertion end of the insert is disposed within the aperture of themain body. In addition, an embodiment provides a method of treating ananeurysm in a blood vessel having a branch vessel near the aneurysm,comprising deploying a modular exclusion device comprising a main bodywith at least one aperture; deploying at least one insert with aninsertion end, where a polymeric compound is disposed within theaperture of the main body, on the insertion end of the insert or bothwithin the aperture of the main body and on the insertion end of theinsert, and where the polymeric compound comes into contact with boththe aperture of the main body and the insertion end of the insert whenthe insertion end of the insert is disposed within the aperture of themain body.

BRIEF DESCRIPTION OF THE DRAWINGS

A more particular description of the embodiments may be had by referenceto the embodiments according to the invention described in the presentspecification and illustrated in the appended drawings.

FIG. 1 is an artist's rendering of a cross section of an aorta showingan aneurysm near the thoracic aortic arch;

FIG. 2A shows an exterior side view of the stent graft useful forexcluding the aneurysm of the aorta shown in FIG. 1;

FIG. 2B is a close-up of one stent graft aperture and an inserttherefore;

FIG. 2C is an exterior side view of the stent graft of FIG. 2A, whereinthe stent graft has been located over a guidewire used for guiding thestent graft, once loaded into a delivery device, to the aneurysmallocation in the thoracic aortic arch of FIG. 1;

FIG. 2D is an exterior side view of FIG. 2C, wherein the stent graft hasbeen compressed for delivery into the delivery device;

FIG. 3 is a cross sectional view of the aneurysmal aorta of FIG. 1showing the deployment of a stent graft, with the stent graft deliverydevice displayed in partial cutaway.

FIG. 3A shows a cross section of the main portion of the stent graftinstalled, with a catheter tracking to deliver a branch insert;

FIG. 4 is an exterior side view of the stent graft of FIG. 2 showndeployed in the aneurysmal aorta of FIG. 1 and further showing extensionof the apertures and the inserts from the upper wall of the stent graftinto the branch arteries of the aneurysmal aorta of FIG. 1;

FIG. 5 is an artist's rendering of a cross section of an aorta showingan aneurysm of the abdominal aorta;

FIGS. 6A and 6B are exterior side views of a stent graft useful forexcluding the aneurysm of an abdominal aorta as shown in FIG. 5; FIG. 6Cshows the stent graft of FIGS. 6A and 6B positioned in an abdominalaorta;

FIG. 7A is an exterior side view of another stent graft useful forexcluding the aneurysm of an abdominal aorta as shown in FIG. 5; FIG. 7Bshows the stent graft of FIG. 7A positioned in an abdominal aorta;

FIGS. 8A and 8B are exterior side views of yet another stent graftuseful for excluding the aneurysm of an abdominal aorta as shown in FIG.5; FIG. 8C shows the stent graft of FIGS. 8A and 8B positioned in anabdominal aorta;

FIG. 9 is an exterior side view of another modular, multi-sectionalstent graft useful for excluding the abdominal aortic aneurysm shown inFIG. 5;

FIG. 10 is an artist's rendering of a cross section of a blood vesselshowing an aneurysm in a branched portion of a blood vessel; and

FIG. 11A is an exterior side view of two parts of a rotation cuff deviceuseful for excluding the aneurysm of the vessel shown in FIG. 10; FIG.11B is an exterior side view showing the two parts of the rotation cuffof FIG. 11A assembled with portions of each cuff shown in phantom; FIG.11C is an exterior side view of the assembled cuff positioned in thebranched region of the vessel shown in FIG. 10.

DETAILED DESCRIPTION

Reference now will be made to details of exemplary embodiments accordingto the invention. It is to be understood that the described embodimentsare not intended to limit the invention solely and specifically to onlythese embodiments.

Methods and apparatus for stabilizing and treating an aneurysm includedeploying a modular, sectional exclusion device, such as a stent graft,in the flow lumen of a blood vessel to span the aneurysmal location andseal off the aneurysmal location of the blood vessel from further bloodflow while acting as a conduit to direct blood flow past the aneurysmalsite. In the case of an aneurysm near a branch artery, methods andapparatus for treatment include positioning a modular endovascular stentgraft in the aneurysmal site, where the stent graft includes a main bodywith at least one aperture, and in some embodiments two or three or moreapertures, where separate individual inserts are disposed within eachaperture to extend sealingly into the exclusion device and sealinglyinto a branch artery. A polymeric compound is used on either the insert,within the aperture or both, to ensure a snug, well-sealed fit betweenthe aperture in the main body and the insert.

In addition to versatility in accommodating branch vessels, modularstents allow for in situ adjustment of insert lengths to accommodatedifferent patient needs. Modular stent grafts are known in the art, andare disclosed in, inter alia, U.S. Pat. No. 6,129,756 to Kugler, et al.;U.S. Pat. No. 5,824,040 to Cox, et al.; U.S. Pat. No. 6,093,203 toUflacker, et al.; U.S. Pat. No. 6,579,312 to Wilson, et al.; U.S. Pat.No. 5,906,641 to Thompson, et al.; and U.S. Pat. No. 5,855,598 toPinchuk, et al., all of which are incorporated by reference in theirentireties in for all purposes.

Each of the apertures of the main body of the stent graft is alignablewith, and extendable into, a branch artery to aid in maintainingalignment of the aperture with the branch artery for providingadditional positional stability for the deployed stent graft. The stentgraft excludes the weakened vessel wall at the aneurysmal site fromfurther exposure to blood flowing through the aorta, but, as a result ofthe aperture, allows blood to flow from the aorta to the branchartery(ies), even where the main body of the stent graft extends acrossthe branch artery(ies). Inserts are then provided to fit sealingly intoeach aperture and further extend sealingly into the branch vessels,thereby preventing leakage of blood from the branch arteries into theregion between the stent graft and the weakened blood vessel wall at theaneurysmal location. A polymeric compound strengthens the seal betweenthe main body of the stent graft and the insert.

Referring initially to FIG. 1, there is shown an aneurysm of theabdominal aorta 10, such that the aorta is enlarged at an aneurysmallocation 14 wherein the aorta wall 12 is distended and stretched. Theaneurysmal location 14 forms an aneurysmal bulge or sac 18. If leftuntreated, the aneurysmal portion of the aorta wall 12 may continue todeteriorate, weaken, and eventually tear or burst. The aorta 10 extendsupwardly from the heart (not shown), such that at the aortic arch 50,three branching arteries, the brachiocephalic trunk 56, the left commoncarotid artery 54 and the left subclavian artery 52, extend from aorta10.

FIG. 2A is an exterior side view of a modular stent graft that may beused to treat the aneurysm in FIG. 1 and that incorporates, as will bedescribed further herein, a polymeric compound in one embodimentaccording to the present invention. There is shown generally a main bodyof the stent graft 20 comprising a tubular stent frame (framework) 22and a graft material 24 attached to the stent frame 22 such as by sewingthe graft material 24 to the stent frame 22, which together form anintegral tubular structure having a profile substantially mimicking thatof a healthy thoracic aorta. In one aspect, the stent frame 22 may beformed of a plurality of wires, each of the wires bent into a zig-zagconfiguration and joined at its opposed ends to form a continuous hoop.The individual wires are then interconnected by a plurality of spanningwires, which are crimped at their opposed ends which are crimped toadjacent formed wires to form the support structure of the stent frame22. This support structure is attached to the graft material 24, such asby sewing the two portions together, and then positioned in the aorta topush against the aorta wall 12 and support the graft material 24 so asto enable the graft material 24 to seal against healthy portions of theaorta wall 12 and to provide a conduit through which blood flows andbypasses the aneurysmal location 14 of the aorta 10.

In the stent graft shown in FIG. 2A, there are three apertures(generically at 60) extending from the main body 21 of the stent graft20, specifically apertures 62, 64 and 66, extending from the wall of themain body of the stent graft 20. Referring back to FIG. 1, when thestent graft 24 is deployed in the aorta 10, aperture 66 accommodates theexit of the brachiocephalic trunk 56 from the aortic arch 50, aperture64 accommodates the exit of the left common carotid artery 54 from theaortic arch 50 and aperture 62 accommodates the exit of the leftsubclavian artery 52 from the aortic arch 50. In addition to thebrachiocephalic trunk, the carotid artery and the left subclavianartery, other branched vessels (not shown) may be present and would beaccommodated by one or more apertures as appropriate.

FIG. 2A also shows three inserts 72, 74 and 76, having both stent frame22′ and graft 24′ components, i.e., each of the inserts 72, 74 and 76are configured with a stent frame sized to be slightly larger than thecircumference of the branch artery into which it is inserted, and has atubular length of graft 24′ material sewn or otherwise affixed thereto.Insert 76 is configured to be inserted into aperture 66 whichaccommodates the exit of the brachiocephalic trunk 56 from the aorticarch 50 and which supports the vasculature thereof; insert 74 isconfigured to be inserted into aperture 64 which accommodates the exitof the left common carotid artery 54 from the aortic arch 50 and whichsupports the vasculature thereof; and insert 72 is configured to beinserted into aperture 62 which accommodates the exit of the leftsubclavian artery 52 from the aortic arch 50 and which supports thevasculature thereof.

The materials making up the stent frame portion of the stent graftand/or insert(s) may be a metal, such as stainless steel, nitinol (NiTi)or tantalum (Ta), all known well in the art. In addition, various ironalloys such as iron platinum, iron palladium, iron nickel cobalttitanium, iron nickel carbon, iron manganese silicon, and iron manganesesilicon chromium nickel. Generally the diameter of the metal wire/tubeused for construction of the stent is between about 0.005 inches toabout 0.02 inches. When nitinol is employed, the stent graft may haveshape memory characteristics. While a braided construction of the stentframe is shown, this depiction is merely representative of any one ofthe numerous stent frame structures used to support stent grafts as iswell known by persons skilled in the art.

The material composing the graft 24 of the stent graft 20 may be anybiocompatible material that is mechanically stable in vivo, and iscapable of preventing or substantially reducing the possibility of thepassage or flow of blood or other body fluids there through. Typicalmaterials for graft 24 include biocompatible plastics such asimplantable quality woven polyester. Such polyester material may alsoinclude, therewith, components such as collagen, albumin, of anabsorbable polymonomer or of a biocompatible fiber. Additionally,non-resorbable elastomers or polymers such as silicone, SBR, EPDM,butyl, polyisoprene, Nitril, Neoprene, nylon alloys and blends,poly(ethylene-vinyl-acetate) (EVA) copolymers, silicone rubber,polyamides (nylon 6, 6), polyurethane, poly(ester urethanes), poly(etherurethanes), poly(ester-urea), polypropylene, polyethylene,polycarbonate, polytetrafluoroethelene, expandedpolytetrafluoroethelene, polyethylene teraphthalate (Dacron)polypropylene and polyethylene copolymers.

In the embodiments shown herein, where the stent graft 20 furtherincludes apertures such as apertures 62, 64 and 66 which align withbranch arteries adjacent to the aneurysmal site 14, and also receives aninsert such as insert 72, 74 and 76 in each of the apertures, theinserts, and optionally the region of the apertures 62, 64 and 66 intowhich the inserts are received, may be formed of or coated with anon-resorbable polymer such as polymethylsiloxane, polydimethylsiloxaneor polymethylphenylsiloxane or silicone. For example, each of theinserts 72, 74 and 76 may comprise a stent graft type structure, ontowhich a non-resorbable polymer, including polyurethane, silicone,polymethylsiloxane, polydimethylsiloxane or polymethylphenylsiloxane arecoated thereon. The coating can be accomplished by sewing or adheringstrips of the polymer to the mating surfaces of the inserts andapertures, by spray coating, by dip coating or vapor coating thematerials thereon. Additionally, the inserts, and/or the apertures maybe formed of a compound material formed, such as, for example, by insertmolding wherein the aperture (62, 64 or 66) portions of the stent graft20 are held in a mold and a polymer such as silicone is molded thereto.Where the stent frame 22 portion of the stent graft 20 is composed of ashape memory material, the material(s) selected to coat the aperturesmust also be able to withstand, without degradation of its mechanicalproperties which would render it incapable of sealing against itself,temperatures sufficiently low, on the order of the temperature of liquidnitrogen, to allow the tubular stent graft to be compressed into a smalldiameter structure for insertion into a delivery catheter as will befurther described herein.

In one aspect, the non-resorbable polymer may be silicon, which is dipcoated or insert molded to appropriate portions where the stent graft 20and inserts 72, 74 and 76 engage one another in intended sealingcontact. The silicone may be, for example, simply adhered to the stentgraft 20 inner surfaces about the inner perimeter of the apertures 60,such as by lowering or placing the apertures 60 over a mandrel or rodhaving an as yet uncured, substantially viscous silicon located thereon.This could be performed, for example, by dipping the rod into a bath ofuncured silicone, such that a film of silicone forms thereon, and matingthe rod to the interior of the apertures. Likewise, the rod could berolled over the exterior surface of the portion of the inserts 72, 74and 76 which are to be received in the apertures, and thus the siliconewill become adhered to, and thus deployed on, the surface of the inserts72, 74 and 76. The silicone is then allowed to cure, either in air atatmospheric temperature and pressure conditions, or in an oven atelevated temperature.

The stent graft 20 and inserts 72, 74 and 76 of FIG. 2A show twodifferent paradigms for use of the polymer on the components for sealingof the inserts 72, 74 and 76 to the apertures 60. Insert 76 and aperture66 are coated with the polymer entirely about the circumferential matingor contacting position of the insert 76 to the aperture 66. In thiscase, the coating 65 extends entirely about the circumference of theinsert 76 and from the end thereof which is received in the aperture 66by a distance equal to the length by which the insert 76 is received inthe aperture 66. Likewise, coating 65′ is received in aperture 66substantially about its entire projected length. In contrast, apertures62 and 64, and likewise inserts 72 and 74, demonstrate a differentaspect, in which a continuous circumferential coating of the polymer isreplaced by a series of longitudinal stripes 67 extending along theouter surface of the inserts 72, 74 and stripes 67′ of the polymerextend longitudinally along the inner surface of the apertures (apertureprojection or nozzles) 62, 64 into which the inserts 72, 74 arereceived. In this aspect, the polymer stripes reduce the bulk ofmaterial and the circumferential stiffness of the stent graft, byleaving open spaces of bare graft material between the longitudinalstripes 67. Thus, in one example, such a configuration provides analternate back and forth folding pattern as the stent graft diameter isreduced to its compressed state for delivery within the delivery system.In such a pattern when folded (compressed), the longitudinal stripes arenot in contact with any adjacent longitudinal stripes, but only with thebare graft or stent frame materials, so that premature melding ofpolymer stripes to one another does not occur to cause sticking betweenadjacent folds when the stent graft is deployed (expanded). In thisaspect, the inserts 72, 74, when received in their respective apertures62, 64, are configured and positioned such that a portion of the stripeson the inserts 72, 74 contacts a portion of the stripe on the aperture.

The thickness of the graft material optionally is minimized to reducethe overall cross sectional thickness of the stent graft 20 and thus thesize of the stent graft 20 as deployed in a delivery catheter.Generally, the graft material will be thinner than about 0.005 inch, andmay be thinner than about 0.002 inch.

In the embodiment of the stent graft 20 shown in FIG. 2A, the ends ofthe graft material 24 extend beyond the marginal edges of the stentframe 22, i.e., the graft material 24 extends axially beyond the opposedgenerally circular ends of the stent frame 22 to form opposed ends 26,28 of the stent graft 20. This arrangement is one of variousarrangements of the position of the graft 20 portion with respect to thestent 22, as in other embodiments according to the present invention theends of the graft portion 24 are coincident with the opposed ends of thestent frame 22 or the ends of the stent frame 22 may extend beyond themarginal ends of the graft portion 24. The ends of the graft portion 24of the stent graft 20 are preferably configured to prevent fraying,which may be accomplished by heat fusion or binding of the edge of thegraft portion 24 or by folding the end of the graft portion 24 back uponitself and sewing it to the stent frame 22 or to itself. Also, the graftportion 24 may be located on the interior of the stent frame 22, on theexterior of the stent frame 22, or the graft portion 24 may be locatedin the interstitial spaces between the portions or sections of the stentframework (shown as a braided pattern in the Figures herein). The graftportion 24 may include more than one layer or ply. The graft 24preferably is sufficiently non-porous to prevent blood from leaking intothe aneurysmal sac 18 (FIG. 1). In some embodiments, the materialforming the graft portion 24 may include a coating of non-porousmaterial over one or more porous layers. The graft portion 24 isattached the stent frame 22, typically as by sewing the graft 24 to thestent frame 22, but the use of an adhesive, heat bonding of the graft 24to the stent frame 22, or other methodologies are specificallyconsidered acceptable so long as the integrity of the connection of thegraft 24 to the stent frame 22 is maintained.

FIG. 2B is a close up of one example aperture 66′ of the type shown inthe group of apertures 60 formed on the main body 21 of the stent graft20, and an example of an insert 76′ of the plurality of inserts 72, 74and 76 from FIG. 2A. In this embodiment, the inserts such as insert 76shown in FIG. 2A are not coated with a polymer or other sealing andsecuring material, but instead a ring 82 of the sealing or securingmaterial such as silicone is sewn or otherwise attached to the insert,and likewise a ring 82′ of the sealing or securing material is securedwithin the inner circumference of the aperture 66′ into which insert 76′is to be deployed. As shown in FIG. 2B, the aperture 66′ (as well assimilar adjacent apertures (not shown) like apertures 62, 64) preferablyhave a neck portion 80 which extends outwardly, in a tubular crosssection, from the main body 21′ of the stent graft 20′, and includes aring 82′ formed thereon in the manner previously discussed. The insert76′ (and likewise adjacent inserts) is secured within the aperture 66′by friction between the conformable mating polymeric surfaces. Inaddition, where the material of the rings 82, 82′ is a polymer having alow glass transition temperature, the area of contact between twoadjacent rings 82, 82′ will fuse together over time in situ (as it willin the other examples where polymer to polymer contact is described).Additionally, a portion of the insert 76 extends outwardly from the mainbody 21′ of the stent graft beyond the end of the neck portion 80 of theaperture 66′ and is positioned against the wall of the branch vesselinto which it is deployed, preventing leakage of blood or other fluidspast the apertures (e.g., 62, 64 and 66) of the stent graft 20, whileallowing blood to flow through the inner tubular portion of both theapertures (e.g., 62, 64 and 66) and the inserts (e.g., 72, 74 and 76).

To deploy the stent graft 20 endovascularly, the stent graft 20 must beconfigured to fit within a tubular catheter. To accomplish this, themain body 21 of the stent graft 20 is first compressed, as shown in FIG.2C, and then further folded or compressed to the configuration(diameter) of FIG. 2D at which time it may be inserted into the end of acatheter such as catheter 30 shown in FIG. 3. During the compressing ofthe stent graft 20, a guide wire catheter 33 may first be extendedtherethrough, as is also shown in FIG. 2C. The guidewire catheter 33 isa hollow tube through which a guidewire 31 (FIG. 3) is passed, andsupports, at its distal end thereof, an insertion end 32 (catheter tip)through which guidewire 31 likewise extends (FIG. 3). For deployment ofthe stent graft 20, the guidewire catheter 33 extends within the lengthof the tubular catheter 30 such that its distal end is attached to theinsertion end 32 and its proximal end is manipulable by a technician orsurgeon to position the distal end in relative proximity of thedeployment location. Where the stent frame 22 portion of the main body21 of the stent graft 20 is configured of a shape memory material, suchas nitinol, the main body 21 can be first cooled to a very lowtemperature, such as by using sprayed bursts of liquid nitrogen whichdepending on the composition of the nitinol can make the nitinolplastically deformable an easier to load, before it is compressed (asshown in FIGS. 2C and 2D.) Where the stent portion 22 is comprised of anon-shape memory material, an inflation device such as a balloon 34 onthe guidewire catheter 33 connected to an end of an inflation lumen 38extending along the guidewire catheter 33 is first located inside of thetubular shape of the main body 21, onto which the stent graft can becompressed. Likewise, inserts 72, 74 and 76 can be compressed and placedin separate catheters, one such catheter shown as catheter 30′ in FIG.3A. Each insert may be located in a single catheter, or all of theinserts necessary to deploy one into each of the apertures 60 may bedeployed in a single catheter, with one insert closest to the open endthereof, and the next one(s) stacked therebehind. Additionally, wherethe inserts are configured incorporating a non-shape memory alloy as thestent material, a balloon must be first placed inside the tubular volumebefore compressing it. This can be unnecessary where the insert is selfexpanding. It is also possible that the insert is compressed over thesmaller balloon and is able to adhere to the balloon without the use ofan outer sheath.

Referring still to FIG. 3, the initial deployment of the stent graft 20into the thoracic arch into an aneurysmal location 14 spanning positionis shown. Prior to the deployment of the stent graft 20, a guide wire 31is extended from a remote blood vessel incision site leading to the arch50, and through the arch 50, such that the inserted end thereof extendspast the intended location of the deployed stent graft 20. To positionand properly locate the stent graft 20 in a spanning, sealed position inthe aneurysmal location 14, the stent graft 20 is introduced through anartery, such as the femoral artery (not shown), by inserting thecatheter 30 into the artery through an incision in the leg. The catheter30 preferably includes an outer sheath portion enclosing a collapsed orcompressed stent graft 20 held within a distal end of the sheath 30which is introduced into the patient's artery and from which the stentgraft 20 is deployed. A proximal end of the catheter (not shown) ismaintained external to the body and is manipulated to axially androtationally position catheter within the aorta 10. At least one pushrod 36 can extend within the catheter 30, from a position adjacent tothe distal end of the stent graft 20 within the hollow portion of thecatheter 30, to a position beyond the proximal end of the catheter 30.Additionally, where a balloon is employed in the deployment of thecatheter, a lumen 38 capable of introducing saline extends from aballoon 34 within the stent graft 20 to a position beyond the proximalend of the catheter 30 where it is connectable to an inflation device.Catheter 30 and any other catheters required for deployment typicallycarry radiological markers on their outer surface adjacent thedeployment end 38, to enable the surgeon deploying the stent graft todetermine the position of the catheter in the body, such as byfluoroscopic or other means. Additionally, the stent graft 20 hasradiological markers thereon to enable determination of the position androtational orientation thereof at the aneurysmal location.

In deploying the stent graft 20, catheter 30 is tracked through thepatients' artery, until the end thereof is disposed in the archphysically beyond the aneurysm location 14. The push rod 36 which islocated against the distal end of the stent graft 20 within catheter 30,and holds the stent graft 20 stationary as the tubular sheath of thecatheter 30, is withdrawn or retracted with respect to the aneurysmallocation 14. As the sheath retracts, the stent graft 20 is progressivelyreleased from the sheath in a position spanning across the aneurysmallocation 14 of the aorta. As the catheter sheath is withdrawn with thepush rod 36 held stationary, and as the deployment of the stent graft 20is beginning, the catheter 30 may be rotated to ensure that the mainbody 21 of the stent graft 20 deploys with the apertures 62, 64 and 66in alignment with the branch arteries 52, 54 and 56.

The stent graft apertures 62, 64, and 66 are, when the stent graft 20 isproperly aligned in the aorta 10 and arch 50, aligned with the brancharteries 52, 54 and 56, and expanded to extend outwardly from the wallof the stent graft 20. In the configuration of the embodiment of thestent graft in FIGS. 2A and 3, three branch arteries must be spanned andthus three apertures 60 are provided. Alternatively, where the size andlocation of the aneurysmal sac 18 enables a shorter length of stentgraft to ensure sufficient sealing of the stent graft against the wallof the aorta, or, where the aneurysmal sac is more remotely located fromthe branch artery locations, the stent graft may be deployed with feweropenings therein, and an aperture 60 need only be located in each ofthose openings. After the main body 21 of the stent graft 20 isdeployed, the balloon, where used, is deflated and withdrawn along withthe catheter 30.

A separate catheter, e.g., 30′, may be used to deploy each insert 72, 74and 76 into each separate aperture 62, 64 and 66. This is provided bydeploying additional catheters in a number equal to the number ofinserts used, through the artery and within the stent graft 20, andextending each catheter along a guidewire into individual stent graftbranches 60. To direct the catheters into the appropriate apertures 60,a guide wire 31′ is first deployed and guided into and past theappropriate aperture and a further distance along the appropriate branchartery 52, 54 or 56. The catheter is positioned such that the distal endof the catheter is disposed inside of the aperture and branch vesselwhere the insert in the branch vessel will be located. As with thedeployment of the main body 21, the sheath of the catheter 30′, with apush rod (not shown) positioned against an insert 72, 74 or 76, iswithdrawn and the insert 72, 74 or 76 deploys, with the shape memorymaterial expanding to the expanded diameter of the tubular section ofthe insert 72, 74 or 76, with the outer surface thereof engaged with theinner surface of the aperture to sealingly secure the insert 72, 74 or76 therein by an interference or friction fit, with the portionextending outwardly therefrom in sealing engagement with the adjacentwall of the particular branch vessel 50 into which it is deployed. Whereshape memory material is not used, a balloon is positioned within theinsert 72, 74 or 76, to cause its expansion. This procedure is repeated,with repositioning of the guidewire and redeployment of the catheter30′, until all of the needed inserts are deployed. Once the stent graftmain body 21 and inserts 72, 74 and 76 are deployed, all balloons (whereneeded) are deflated, the catheters and guidewires are withdrawn, andthe artery and leg incision(s) are closed. The stent graft 20 andinserts 72, 74 and 76 are thus positioned, spanning the branch arterieswithout blocking them. Methods and apparatus for the deployment ofsectional stent grafts are also disclosed in U.S. Pat. No. 5,683,451 toLenker, et al.; U.S. Pat. No. 5,713,917 to Leonhardt, et al.; and U.S.Pat. No. 5,984,955 to Wisselink, et al., all of which are incorporatedby reference in their entireties in for all purposes.

Once the inserts 72, 74 and 76 are positioned in the respectiveapertures 62, 64 and 66, the contacting surfaces of the polymer disposedon both the apertures 62, 64 and 66 and the inserts 72, 74 and 76provide both sealing of the insert-aperture interface, but likewiseprovide increased friction due to the polymer to prevent the movement ofthe inserts with respect to the apertures. Over time, the interface ofthe (polymer) sealing materials may meld together to form a continuousadhering material between the insert and the aperture. However, theability of these materials to meld together is, in part, based upontheir tackiness, i.e., the ability or desire of the material to stick tomaterials into which it comes in contact. This property may affect theability to deploy the apertures 62, 64 and 66 and the inserts 72, 74 and76, as the sealing and securing material thereon, for example thecoating 65 or 65′, may come into contact with itself during thecompressing of the stent graft 20 or the inserts 72, 74 and 76 for theplacement thereof into catheters. To minimize the risk that theapertures of the stent graft 20 or the inserts 72, 74 and 76 will becomeadhered together in the collapsed state, three construction and/ordeployment paradigms may be used: Firstly, a balloon may be providedwithin the envelope of each of the apertures 62, 64 and 66 and inserts72, 74 and 76, such that the inflation thereof, in situ, will overcomeany sticking of the material 65 to itself. Secondly, the sealing andsecuring material may be comprised as stripes 67, 67′, as shown in FIG.2A, such that upon compressing of the stent graft 20 or the inserts 72,74 and 76, the stripes 67, 67′ of sealing and securing material contactstent 22 or graft 24 material, and not an adjacent stripe 67, 67′.Thirdly, the coating 65, 65′ may, prior to the compressing andconfiguring of the stent graft 20 and the inserts 72, 74 and 76, becovered with a release, material, such as a thin sheet of PTFE or FEPmaterial, which material is adhered likewise to a wire or other catheterdeployable member which can be pulled outwardly of the patient, duringthe deployment of the stent graft 20 or inserts 72, 74 and 76, to pullthe sheet off of the polymer prior to the contact of the polymercarrying portion of the insert 72, 74 or 76 with its appropriateaperture 62, 64 or 66. Thus, the stickiness or tackiness of the polymermay be used to help secure and seal or meld the insert and aperturetogether, while the inserts 72, 74 and 76 and apertures 62, 64 and 66are expandable in situ.

Referring to FIG. 4, once deployed, the stent graft 20 is intended toprovide a flow conduit across the aneurysmal sac 18 of the aorta 10, andto seal off the aneurysmal sac 18 from further blood flow. The stentgraft 20 is sized so that, upon deployment in the aorta 10, the diameterof the stent graft 20 is slightly larger than the normal, healthydiameter of the aorta 10 so that the opposed ends 26, 28 of the stentgraft 20 are in apposition with the inner wall of the aorta 10. Further,the stent graft 20 is long enough to span the aneurysmal sac 18 of theaorta 10 and sealingly contact the aorta wall 12 on opposite sides ofthe aneurysmal sac 18. Such sealing includes the region of the aortawall 12 between the branch arteries 52, 54 and 56, as well as regionsdistal and proximal from the aneurysmal region 18. To enable sealing bythe stent graft 20, the stent graft includes a circumferential wall,which, at opposed ends 26 and 28, is engageable against the inner wall12 of the aorta 10 to effect sealing and prevent, when properlydeployed, blood flow into the aneurysmal sac 18 of the aorta 10.Additionally, the inserts 72, 74 and 76 extend into the branch arteries52, 54 and 56, providing an extended conduit for blood flow therebyexcluding blood from the region of the branch vessels where vesseldelamination (dissection) may occur.

Where FIG. 1 shows an aneurysm near the thoracic aortic arch, FIG. 5 isan artist's rendering of an aorta showing an aneurysm in the abdominalaorta. FIG. 5 shows an aorta 110 with an aortic wall at 112. There is ananeurysmal site at 114, defining an aneurysmal sac at 118. Renalarteries are seen at 116, the right iliac artery is seen at 119 and theleft iliac artery is seen at 117.

FIGS. 6A and 6B are schematic exterior side views of a stent graftuseful for excluding an aneurysm of the aorta shown in FIG. 5. FIG. 6Ashows a main body of the stent graft 120 generally, with a stent frame122 and graft portion 124. In addition, stent graft 120 has a secondbranch insertion site 125, as well as a polymeric compound 182 such as apolymeric compound such as that used in conjunction with the inserts andapertures of the embodiment shown in FIGS. 2, 3 and 4 disposed insidethe insertion site (shown in phantom). Also in FIG. 6A, there is aninsert 170 having an insertion end 171, likewise comprised of a stentframe portion 122 and graft portion 124. On insert 170, there isdisposed, at 180, a polymeric compound such as that used in conjunctionwith the inserts and apertures of the embodiment shown in FIGS. 2, 3 and4.

FIG. 6B shows the main body of the stent graft 120 and insert 170 ofFIG. 6A assembled. In FIG. 6B, insertion end 171 of insert 170 isdisposed within the main body of the stent graft 120, such that thepolymeric compounds 180, 182 on the insert 170 and the main body of thestent graft 120 engage against one another.

FIG. 6C shows the assembled stent graft and insert from FIG. 6Bpositioned within an abdominal aortal region of FIG. 6A. The aorta 110shows an aorta wall at 112, an aneurysmal region at 114 and ananeurysmal sac at 118. The renal arteries are seen at 116, the leftiliac artery is seen at 117 and the right iliac artery is seen at 119.Stent graft 120 and insert 170 are shown with stent portions 122 andgraft portions 124. The insertion end of insert 170 is shown at 171. Thestent graft 120 and insert 170 are deployed similar to how stent graft20 shown in FIGS. 2, 3 and 4 is deployed, i.e., the main body stentgraft 120 is tracked, in a catheter, up the right iliac artery 119, anddeployed from the catheter and positioned as shown in FIG. 6C. Theinsert 170, which forms the contralateral leg of the assembled stentgraft, is tracked in a catheter up the left iliac artery 117, such thatthe end thereof having the polymeric compound 180 thereof is insertedinto the opening 125 of the stent graft 120, and then inflated orotherwise restored to its free state such that polymer portions 180 and182 contact one another.

FIG. 7A is an exterior side view of an upper portion of an example of acustom configured stent graft useful for excluding an aneurysm of anaorta as shown in FIG. 5. FIG. 7A shows a main body of a stent graft120′ generally, with stent frame/support portions 122′ and graftportions 124′. In addition, stent graft 120′ has branch insertion sites125 a and 125 b that extend radially outwardly from the stent graft 120′and which align with the renal arteries (not shown) when the stent graft120′ is deployed. Polymeric compound 182, such as the polymeric compoundused in conjunction with the inserts and apertures of the embodimentshown in FIGS. 2, 3 and 4, is disposed inside the insertion sites 125 aand 125 b. Also shown in FIG. 7A, are inserts 170 a and 170 b havingmating ends 171 a and 171 b, on which is disposed the polymeric compoundat 180. The embodiment of the stent graft 120′ of FIG. 7A furtherincludes two fenestration extensions at 127 a, 127 b with the polymericcompound 184 disposed on the outer surface thereof. The fenestrationextensions accommodate the celiac trunk and the superior mesentericartery (not shown) when the stent graft 120′ is deployed.

FIG. 7B shows the upper portion of the stent graft 120′ from FIG. 7Aassembled with two additional portions positioned within an abdominalaortal region. The aorta 110 has an aorta wall at 112, an aneurysmalregion at 114 and an aneurysmal sac at 118. Renal arteries are seen at116, the left iliac artery is seen at 117 and the right iliac artery isseen at 119. The stent graft 120′ consists of five portions: an upperportion 121 along with inserts 170 a and 170 b seen in FIG. 7B, as wellas inserts 170 c attached to the open lower end of upper portion 121 andincluding a leg which accommodates right iliac artery 119, and an insert170 d which forms a leg and extends from an opening in the insert 170 cinto sealing engagement with the left iliac artery 117. Inserts 170 a,170 b, 170 c and 170 d each have insertion ends 171 a, 171 b, 171 c and171 d, respectively, with the polymeric compound disposed thereon.

In addition, FIG. 7B shows fenestration extensions 127 a, 127 b fromFIG. 7A. Fenestration extension 127 a accommodates the superiormesentery artery (not shown), and fenestration extension 127 baccommodates the celiac trunk (not shown). Polymeric compound 184 a and184 b is disposed on the outer surface of the fenestration extension toprovide enhanced sealing of the fenestration extension with the brancharteries.

FIGS. 8A and 8B are exterior side views of yet another configuration ofstent graft useful for excluding the abdominal aorta shown in FIG. 5.FIG. 8A shows a main body 120″ of a stent graft and an insert 170″.Again, both the main body 120″ of the stent graft and insert 170″ havestent portions at 122″ and graft portions at 124″. The main body 120shows an insertion site 125 for insert 170″ as well as polymericcompound 182″, a polymeric compound such as that used in conjunctionwith the inserts and apertures of the embodiment shown in FIGS. 2, 3 and4, disposed within the inside rim of the insertion site. Insert 170″shows an insertion end at 171″ as well as the polymeric compound at 180″shown applied around the insertion end. FIG. 8B shows the main body 120″of the stent graft and the insert 170″ of FIG. 8A assembled. Again,stent frame 122″ and graft 124″ portions are seen on both the main body120″ of the stent graft and the insert 170″. In addition, a portion ofthe insert 170″ is shown in phantom 178″ disposed within the stent graft120. Polymeric compounds 180 and 182 are seen in phantom as well.

FIG. 8C shows the assembled stent graft/insert combination of FIG. 8Bpositioned within an abdominal aneurysm. Again, an aorta is seen at 110,an aortal wall is seen at 112, an aneurysmal region is seen at 118 andan aneurysmal sac is seen at 118. Renal arteries are shown at 116, theleft iliac artery is shown at 117 and the right iliac artery is shown at119. Main body 120″ of stent graft and insert 170″ are also shown.

FIG. 9 is an exterior side view of yet another stent graft useful forexcluding the aneurysm of the abdominal aorta shown in FIG. 5. FIG. 9shows a four-piece modular stent graft, with a main body at 120′″ andinserts at 170 a′″, 170 b′″ and 170 c′″. Stent 122′″ and graft 124′″portions are shown on each of the four modular pieces. Insertion end 171a′″ of insert 170 a′″ is shown, as is insertion end 171 b′″of insert 170b′″ and insertion end 171 c′″ of insert 170 c′″. Polymeric compound, apolymeric compound such as that used in conjunction with the inserts andapertures of the embodiment shown in FIGS. 2, 3 and 4, is shown disposedon the inserts at 180 a′″, 180 b′″ and 180 c′″. In addition, polymericcompound such as silicone is shown disposed within stent graft main body120′″ in phantom at 182 a′″, 182 b′″ and 182 c′″.

FIG. 10 is an artist's rendering of a blood vessel showing an aneurysmadjacent a branch portion of the vessel. FIG. 10 shows an aorta at 210,having aortal branches at 211. The aortal wall is seen at 212, theaneurysmal site is seen at 214 and the aneurysmal sac is seen at 218.

FIG. 11A is an exterior side view of two parts of a rotation cuff deviceuseful for excluding the aneurysm of the vessel shown in FIG. 10. Anouter cuff 290 has a polymeric compound (such as that used inconjunction with the inserts and apertures of the embodiment shown inFIGS. 2, 3 and 4) on various portion of the inner surface. Polymercoating is applied to at least one of the several areas shown. Generallythere is continuous uninterrupted layer covering the coating area,though a striped coating configuration (as discussed above) can also beused. The coating area extends from the edge of the circular aperture(branch) or rectangular aperture outwardly from the opening and providesat least a minimum width contact area for the polymeric compound. Whilepolymeric coatings are here shown on both pieces (outside of the innerone and on the inside of the outer one around both sets of openings),the polymeric coating can be configured with less initially coated area,such that the parts are configured to have a polymer coating in thespace between layers around each branch related opening, when assembled.In this embodiment, edges of the polymer covered areas (coatings) on theinside surface are shown by dashed lines on the outer cuff 290 atopening 294. Opening 294 accommodates the inner cuff aperture 273. Theinsert cuff 270, having an insert aperture at 273 and the insertaperture 284 both have a polymeric compound area 280 disposed aroundtheir edge as shown by the cross hatched area. While rectangular shapedareas for the polymer are shown, other geometric shapes which provide anedge sealing zone or continuous seal completely around the opening canbe used. Opening 284 accommodates the outer cuff aperture 293.

FIG. 11B is an exterior side view showing the two parts 290, 270 of therotation cuff of FIG. 11A assembled. A portion of the inner cuff 270 isseen through opening 294. The outer cuff aperture is seen at 293 and theinner cuff aperture is seen at 273. Areas having polymeric compoundcoatings are shown in dashed and cross hatched lines, 293′ and 273′around outer cuff aperture 293 and inner cuff aperture 273.

FIG. 11C is an exterior side of the assembled cuff of FIG. 11Bpositioned in the branched vessel region shown in FIG. 10. The aorta isseen at 210, the aortal wall is seen at 212, the aneurysmal region isshown at 214 and the aneurysmal sac is shown at 218. Branched arteriesare seen at 216. The assembled cuff device is seen at 300, with outercuff aperture 293 and inner cuff aperture 273 shown.

The stent grafts and cuffs according to the present invention may,optionally, deliver a therapeutic agent by way of a coating on the stentand/or graft material. In such an embodiment, the coating compound isadapted to exhibit a combination of physical characteristics such asbiocompatibility, and, in some embodiments, biodegradability andbio-absorbability, while serving as a delivery vehicle for release ofone or more therapeutic agents that aid in the treatment of aneurysmalor atherosclerotic tissue.

In selecting an appropriate therapeutic agent or agents, one objectiveis to protect the aneurysmal blood vessel from further destruction.Another objective is to promote healing. Generally, aneurysm resultsfrom the invasion of the cell wall by inflammatory agents that cause therelease of elastin and collagen attacking proteins that for unknownreasons begin to congregate at certain blood vessel sites. Attack of theblood vessel structure causes further inflammation and cyclically therelease of more of these elastin and collagen attacking proteins.Inflammation, the elastin and collagen attacking proteins, and theresulting breakdown of tissue, are leading causes of aneurysm formation.

Therapeutic agents useful in embodiments of the present inventioninclude matrix metalloproteinase (MMP) inhibitors, which have been shownin some cases to reduce such elastin and collagen attacking proteinsdirectly or in other cases indirectly by interfering with a precursorcompound needed to synthesize the MMP's. Another class of agents,non-steroidal anti-inflammatory drugs (NSAIDs), has demonstratedanti-inflammatory qualities that reduce inflammation at the aneurysmalsite, as well as an ability to block MMP-9 formation. Cyclooxygenase-2or “COX-2” inhibitors also suppress MMP-9 formation. In addition,anti-adhesion molecules, such as anti-CD18 monoclonal antibody, limitthe capability of leukocytes that may have taken up MMP-9 to attach tothe blood vessel wall, thereby preventing MMP-9 from having theopportunity to attack the blood vessel extracellular matrix. Othertherapeutic agents contemplated to be used to inhibit MMP-9 and possiblyMMP-2 are tetracycline and related tetracycline-derivative compounds.

Steroidal anti-inflammatory drugs such as dexamethasone, beclomethasoneand the like may be used to reduce inflammation. Another class oftherapeutic agent that finds utility in inhibiting the progression of orinducing the regression of a pre-existing aneurysm is beta blockers orbeta adrenergic blocking agents. In addition to therapeutic agents thatinhibit elastases or reduce inflammation are agents that inhibitformation of angiotensin II, known as angiotensin converting enzyme(ACE) inhibitors. ACE inhibitors are known to alter vascular wallremodeling, and are used widely in the treatment of hypertension,congestive heart failure, and other cardiovascular disorders vascularwall injury.

The maximal dosage of the therapeutic to be administered is the highestdosage that effectively inhibits elastolytic, inflammatory or otheraneurysmal activity, but does not cause undesirable or intolerable sideeffects. The dosage of the therapeutic agent or agents used will varydepending on properties of the stent, graft or coating material,including its time-release properties, whether the composition of theother components, and other properties. Also, the dosage of thetherapeutic agent or agents used will vary depending on the potency,pathways of metabolism, extent of absorption, half-life and mechanismsof elimination of the therapeutic agent itself. In any event, thepractitioner is guided by skill and knowledge in the field, andembodiments according to the present invention include withoutlimitation dosages that are effective to achieve the describedphenomena.

While the present invention has been described with reference tospecific embodiments, it should be understood by those skilled in theart that various changes may be made and equivalents may be substitutedwithout departing from the true spirit and scope of the invention. Inaddition, many modifications may be made to adapt a particularsituation, material or process to the objective, spirit and scope of thepresent invention. All such modifications are intended to be within thescope of the invention.

All references cited herein are to aid in the understanding of theinvention, and are incorporated in their entireties for all purposes.

1-22. (canceled)
 23. A method of excluding a site of an aneurysm fromblood flow comprising: delivering a stent graft in a compressedconfiguration to an aortic arch of a patient, the stent graft includinga main body include a main body stent, a main body graft materialcoupled to the stent, and an aperture disposed through a surface of themain body graft material, wherein the aperture includes a neck portionextending outwardly from the main body, wherein the neck portionincludes neck portion graft material extending from and integral withthe main body graft material and a neck portion stent; deploying thestent graft at the aortic arch by radially expanding the stent graftsuch that at least a portion of the main body is in apposition with awall of the aortic arch and the neck portion is aligned one of thebrachiocephalic trunk, the left common carotid artery, and the leftsubclavian artery.
 24. The method of claim 23, further comprising:delivering an insert in a compressed configuration such that a portionof the insert is disposed within the neck portion; and deploying theinsert by radially expanding the insert such that an insertion end ofthe insert is disposed within the neck portion and a second portion ofthe insert extends from the neck portion and within one of thebrachiocephalic trunk, the left common carotid artery, and the leftsubclavian artery.
 25. The method of claim 24, wherein deploying thestent graft comprises aligning the neck portion with the left subclavianartery, and wherein deploying the insert comprises deploying the secondportion of the insert within the left subclavian artery.
 26. The methodof claim 25, wherein delivering the insert comprises delivering theinsert in the compressed configuration within a catheter through thestent graft main body and through the neck portion after the stent grafthas been deployed.
 27. The method of claim 24, wherein at least one ofthe neck portion and the insert includes a polymeric compound differentfrom the neck portion graft material and the insert graft material,wherein the polymeric compound is located on an inside surface of theneck portion graft material, an outside surface of an insertion end ofthe insert graft material, or on both the inside surface of the neckportion graft material and the outside surface of the insertion end ofthe insert graft material.
 28. The method of claim 24, wherein the stentgraft comprises three apertures and three neck portions, whereindeploying the stent graft comprises aligning each of the three neckportions with a corresponding one of the brachiocephalic trunk, the leftcommon carotid artery, and the left subclavian artery; and the insertcomprises three inserts, wherein deploying the insert comprisesdeploying each insert into a corresponding one of the thee neckportions.
 29. The method of claim 28, wherein delivering the insertcomprises delivering each of the three inserts in one catheter.
 30. Themethod of claim 28, wherein delivering the insert comprises deliveringeach of the three inserts in a different catheter.
 31. The method ofclaim 23, wherein deploying the stent graft comprises aligning the neckportion with the left subclavian artery.
 32. The method of claim 23,wherein the stent graft comprises three apertures and three neckportions, wherein deploying the stent graft comprises aligning each ofthe three neck portions with a corresponding one of the brachiocephalictrunk, the left common carotid artery, and the left subclavian artery.33. The method of claim 23, wherein the main body stent is made of shapememory material, and wherein the step of deploying the stent graftcomprises retracting an outer sheath of a catheter to enable the shapememory material to self-expand.
 34. The method of claim 23, wherein thestent graft is compressed over a balloon during the step of deliveringthe stent graft, and wherein deploying the stent graft comprisesinflating the balloon.
 35. The method of claim 23, wherein the main bodystent comprises a wires, each of the wires bent into a zig-zagconfiguration and joined at opposing ends to form a hoop.